Sensor, Blood-gas, In-line, Cardiopulmonary Bypass

Device Code: 798

Product Code(s): DTY

Device Classification Information

Device Type ID798
Device NameSensor, Blood-gas, In-line, Cardiopulmonary Bypass
Regulation DescriptionCardiopulmonary Bypass In-line Blood Gas Sensor.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type510(k)
CFR Regulation Number870.4410 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDTY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID798
DeviceSensor, Blood-gas, In-line, Cardiopulmonary Bypass
Product CodeDTY
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionCardiopulmonary Bypass In-line Blood Gas Sensor.
CFR Regulation Number870.4410 [🔎]
Device Problems
Battery
 6
Battery Problem
 3
Crack
 3
Fluid Leak
 3
Incorrect Or Inadequate Test Results
 3
Monitor
 2
No Display / Image
 2
Leak / Splash
 1
Clip
 1
Break
 1
Total Device Problems 25
TPLC Last Update: 2019-04-02 19:41:43
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